6.4.3 TIFAC (Technology Information Forecasting and
6.4.4 BCIL (Biotech Consortium India Limited) 97
6.4.5 TBSE (Technology Bureau for Small Enterprises)/SIDBI
(Small Industries Development Bank of India) 98
6.5 TOT Related Documentation 99
6.5.1 Confidentiality Agreements 99
Long Answer Type Questions 104
Short Answer Type Questions 104
UNIT 3: Regulatory Affairs and Regulatory Requirements for Drug Approval
7. Regulatory Affairs and its Role 114
7.2 Historical Overview of Regulatory Affairs 115
7.3 Regulatory Authorities 116
7.4 Role of Regulatory Affairs Department 117
7.5 Responsibility of Regulatory Affairs Professionals 119
Long Answer Type Questions 120
Short Answer Type Questions 120
8. Drug Development and Non-Clinical Studies 122
8.1 Drug Development Teams 122
8.2 Non-clinical Drug Development 124
Long Answer Type Questions 128
Short Answer Type Questions 128
9.1 General Considerations of Investigational New Drug (IND)
9.2 Investigator’s Brochure (IB) 131
9.3 New Drug Application (NDA) 132
9.4 Clinical Research/BE (Bioequivalence) Studies 134
9.5 Biostatistics in Pharmaceutical Product Development 136
9.6 Data Presentation for FDA Submissions 138
9.7 Management of Clinical Studies 139
Long Answer Type Questions 139
Short Answer Type Questions 140
UNIT 4: Quality Management Systems
10. Quality and Related Concepts 150
10.4 Comparison Between Quality Control and Quality Assurance 156
Long Answer Type Questions 157
Short Answer Type Questions 157
11. Total Quality Management and Other Quality Management
11.1 Total Quality Management (TQM) 159
11.1.2 Characteristics of TQM 159
11.1.4 Key Elements of TQM 160
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